Medical Device Label Symbols
However since this standard is comprised of further useful symbols it should also be considered. Symbols were derived from iso 15223 medical devices symbols to be used with medical device labels labelling and information to be supplied council directive 9342eec of 14 june 1993 concerning medical devices council directive 90385eec of 20 june 1990 on active implantable medical devices and council directive.
Pdf Do Healthcare Professionals Comprehend Standardized Symbols
En iso 15223 12012 medical devices symbols to be used with medical device labels labelling and information to be supplied part 1.
Medical device label symbols. Medical device symbols in the european union symbols for marking and labeling of medical devices and medical products en 9802008 symbols for medical device labeling standard is withdrawn per 22013. Product label symbols symbol. There are over 20 official languages in europe alone and thousands more worldwide.
General requirements is expected to replace en 980 but as of january 2017 is still not harmonized. The final rule permits the use of symbols in all medical device labeling without adjacent explanatory text referred to as stand alone symbols if certain requirements are met. Fda is issuing a final rule revising medical device and certain biological product labeling regulations by explicitly allowing for the optional use in medical device labeling of stand alone symbols established in an sdo.
Use of symbols in labelingglossary to support the use of symbols in labeling. 21 cfr 820120 21 cfr 801 iso 13485 section 36 bs en iso 15223 1 bs en 1041 applicable sections of the canadian medical device regulation and other international standardsregulations. E n iso15223 12012 symbols to be used with medical device labels labeling and information to be supplied.
The use of symbols in medical device labeling final rule final rule including the requirement for a glossary only applies to symbols that are used to convey information required by or under. This document includes visual examples of the symbols themselves along with their. Medical device labeling standards and symbols selling your medical device in the global marketplace requires you to consider other languages and cultures.
The international standard symbols selected to be used with medical device labels are listed in iso 15223 12016 medical devices symbols to be used with medical device labels labelling and information to be supplied part 1. Iso 15223 1 medical devices symbols to be used with medical device labels labeling and information to be supplied 511 manufacturer indicates the medical device manufacturer as defined in eu directives 90385eec 9342eec and 9879ec. Argons labeling is designed to meet the following standards.
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